FDADecember 2, 2024device
MISHA Knee System Implant Small, Left, REF: 2-1001. MISHA Knee System Implant Small, Right, REF: 2-1002.
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Knee implant may fracture due to a supplier-related issue with one component that has nonconforming geometry at the distal end of the absorber component that may result in a reduced wall thickness and microcracks, which may lead to new or worsening symptoms of discomfort, swelling / edema, pain or stiffness, which may necessitate removal of the device.
What to do
FDA enforcement status: Ongoing
Brands named
moximed
UPCs
0085604700579500856047005801
Recall history
No related federal recalls on record for this brand yet.
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